- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00909818
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients
Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.
The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, DK-2100 Ø
- The Danish Breast Cancer Cooperative Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
operated with breast conserving strategy for:
- invasive breast cancer, pT1-2, pN0-1mi, M0 OR
- carcinoma in situ of the breast
Exclusion Criteria:
- previous radiation of the breast/thorax
- breast implants
- pregnant/lactating
- comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard fractionated radiotherapy
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
|
standard fractionated radiotherapy 50 Gy/25 fractions
|
Experimental: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
|
hypofractionated radiotherapy 40 Gy/15 fractions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Grade 2 or 3 fibrosis 3 years after radiotherapy
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Birgitte Offersen, MD, Ph.D, Aarhus University Hospital
- Study Chair: Erik Jakobsen, MD, Vejle Hospital
- Study Chair: Mechthild Krause, M.D., Prof, University Clinic Carl Gustav Carus Dresden
- Study Chair: Andreas Schreiber, M.D., Ph.D., Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
- Study Chair: Ingvil Mjaaland, M.D., Helse Stavanger HF, Sorlandet Sykehus HF
- Study Chair: Unn-Miriam Kasti, M.D., Kristiansand sykehus
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBCG hypo protocol
- CIRRO IP030209
- The Danish Cancer Society
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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